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Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03426514
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Zhao Ren, Ruijin Hospital

Brief Summary:
This study is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer(TLSC) compared with conventional laparoscopic surgery for colorectal cancer(CLSC).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Three-port Laparoscopic Surgery Procedure: Conventional Laparoscopic Surgery Not Applicable

Detailed Description:
At present,surgical treatments is the main means to cure colorectal cancer(CRC).The use of four or more ports has been routine in most laparoscopic colorectal resections. However,the drawbacks are the need for added manpower, consisting of another assistant to provide counter-traction, as well as costs and the unaesthetic effects of additional ports. In order to minimize surgical trauma, improve cosmesis ,reduce manpower,single-incision laparoscopic surgery (SILS) is attracting increasing attention. But it is challenging and highly demanding techniques. Becoming proficient at three-port laparoscopic surgery can make the transition to SILS more nature.Few studies about three-port laparoscopic surgery for colorectal cancer(TLSC) have been reported currently.More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TLSC. This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 282 eligible patients will be randomly assigned to TLSC group and CLSC group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the the feasibility, safety, and potential benefits of TLSC compared with CLSC.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-center Prospective Randomized Controlled Study of the Three-port Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Actual Study Start Date : March 25, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Three-port Laparoscopic Surgery
Patients with colorectal cancer undergo three-port laparoscopic surgery.
Procedure: Three-port Laparoscopic Surgery
Patients undergo three-port laparoscopic surgery. The surgery will be completed by a surgeon and a camera-person without another assistant. The surgeon will adjust surgical position to expose the operative field with the help of gravity. All the orther operative procedures are the same as conventional laparoscopic surgery.

Experimental: Conventional Laparoscopic Surgery
Patients with colorectal cancer undergo conventional laparoscopic surgery(4 or more ports).
Procedure: Conventional Laparoscopic Surgery
Patients undergo conventional laparoscopic surgery(4 or more ports).The surgery will be routinely completed by a surgeon,a camera-person and another assistant to provide counter-traction.




Primary Outcome Measures :
  1. Early morbidity rate [ Time Frame: 30 days after surgery ]
    morbidity rate 30 days after surgery


Secondary Outcome Measures :
  1. Operative time [ Time Frame: intraoperative ]
    Operative time(minutes)

  2. Intraoperative blood loss [ Time Frame: intraoperative ]
    Estimated blood loss(milliliters,ml)

  3. Lymph node detection [ Time Frame: 14 days after surgery ]
    Lymph nodes harvested(numbers)

  4. Proximal resection margin [ Time Frame: 14 days after surgery ]
    Length of proximal margin (centimeters,cm)

  5. Distal resection margin [ Time Frame: 14 days after surgery ]
    Length of distal margin (centimeters,cm)

  6. Length of stay [ Time Frame: 1-14 days after surgery ]
    Duration of hospital stay(days after surgery)

  7. Postoperative recovery course [ Time Frame: 1-14 days after surgery ]
    Time to first ambulation, flatus, liquid diet and soft diet (hours after surgery)

  8. Pain score [ Time Frame: 1-3 days after surgery ]
    Postoperative pain is recorded using the visual analog scale (VAS) pain score (0-10 points)tool on postoperative day 1, 2, 3 and the day of discharge

  9. 3-year disease free survival rate [ Time Frame: 36 months after surgery ]
    3-year disease free survival rate

  10. 5-year overall survival rate [ Time Frame: 60 months after surgery ]
    5-year overall survival rate



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) <30 kg/m2
  • Tumor located in colon and high rectum (the lower border of the tumor is above the peritoneal reflection)
  • Pathological colorectal carcinoma
  • Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
  • ECOG score is 0-1
  • ASA score is Ⅰ-Ⅲ
  • Informed consent

Exclusion Criteria:

  • Previous gastrointestinal surgery
  • History of inflammatory bowel disease
  • History of familial adenomatous polyposis(FAP)
  • Pregnant woman or lactating woman
  • Severe mental disease
  • Intolerance of surgery for severe comorbidities
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
  • Requirement of simultaneous surgery for other disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426514


Contacts
Contact: Ren Zhao, MD +86-18917762018 rjzhaoren@139.com

Locations
China, Shanghai
Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Tao Zhang, MD    +86-13918805942    woodyhom@yahoo.com   
Sponsors and Collaborators
Ruijin Hospital
Investigators
Study Chair: Tao Zhang, MD Ruijin Hospital

Publications:
Responsible Party: Zhao Ren, Chief Physicion, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03426514     History of Changes
Other Study ID Numbers: RJ-TLSC-2018
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhao Ren, Ruijin Hospital:
Colorectal cancer
Laparoscopic surgery
Three-port

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases